Request that the FDA provide an explanation as to why they (the FDA) permitted the removal of the following information from the FDA Betaseron labeling information in versions SUPPL-5195 | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2025-P-5932

Request that the FDA provide an explanation as to why they (the FDA) permitted the removal of the following information from the FDA Betaseron labeling information in versions SUPPL-5195

Documents

Comments

Description

Open

Key Dates

Comment Period OpensNov 7, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Interim Response Letter from FDA CDER to Kaylin Bower	Apr 27, 2026	--

Keywords

CDER

Citizen Petition

Request that the FDA provide an explanation as

to why they (the FDA) permitted the removal of

the following information from the FDA Betaseron

labeling information in versions SUPPL-5195 and

above: “The exact relationship between MRI

findings and clinical status of patients is

Data from Regulations.gov